| Primary Device ID | 00853114006365 |
| NIH Device Record Key | 39694f98-e6bd-42d7-9530-5a4de083dd02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drill Guide |
| Version Model Number | 1405-2587 |
| Company DUNS | 054808082 |
| Company Name | TREACE MEDICAL CONCEPTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853114006365 [Primary] |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
[00853114006365]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-21 |
| Device Publish Date | 2022-10-13 |
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| 00810111220002 | Staple Drill Guide |
| 00853114006365 | Drill Guide - Tall |
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| 00810111221535 | Staple Drill Guide |
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| 00810111223591 | Drill Guide - 15.5MM |
| 00810111223690 | Akin Drill Guide |
| 00810111223720 | Drill Guide and Template |
| 00810111222143 | Drill Guide and Template |
| 00810111224499 | Drill Guide and Template |